On June 14, 2022 Boehringer Ingelheim reported the signing of an option to acquire Trutino Biosciences Inc. (the "Transaction"), a San Diego-based biotech company (Press release, Boehringer Ingelheim, JUN 14, 2022, View Source [SID1234615982]).

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Trutino Biosciences is a pre-clinical stage biotech company dedicated to the discovery and development of next-generation cytokine therapies to treat immuno-oncology and autoimmune diseases. Boehringer Ingelheim is dedicated to a two-pronged research strategy to fight cancers: through cancer cell-directed and immune cell-targeting compounds. The ongoing research partnership between Boehringer Ingelheim and Trutino is part of an overarching effort to mobilize a patient’s immune system to fight cancer.

"Boehringer Ingelheim is excited to extend our partnership with Dr. Kim and his outstanding team at Trutino Biosciences. Our existing collaboration has made rapid and impressive progress in a short time frame, and we expect this field to have potential combination benefits with our existing immune-targeting assets," said Clive R. Wood, Ph.D., Corporate Senior Vice President and Global Head of Discovery Research, Boehringer Ingelheim. "The selective activation of specific cytokines localized in the tumor microenvironment holds enormous promise and has the potential to be a key element in fully harnessing the power of the immune system to fight cancer."

"It’s been two years since our initial strategic alliance began and we are very excited to further strengthen our partnership with Boehringer Ingelheim, a leader in cancer immunology, to advance potential cytokine therapeutic options that will transform the lives of cancer patients worldwide," said Phillip Kim, Ph.D., MBA, Founder and CEO of Trutino Biosciences. "Boehringer Ingelheim has a deep commitment to our innovative scientific approaches and to bringing novel cancer therapies to patients. This global partnership validates the broad potential of our proprietary ‘On Demand Cytokine’ platform. As part of this expanded collaborative framework, we aim to rapidly develop a new generation of cytokine therapies as single agent and in combination with Boehringer Ingelheim’s pipeline portfolio of cancer vaccines, oncolytic viruses, T cell engagers and other therapeutic modalities."

Under the agreement, Boehringer Ingelheim reserves the right to purchase all shares of Trutino Biosciences once specified program milestones have been achieved within a given timeframe. Until that time, Trutino will continue to operate as an independent company, with the existing fruitful strategic partnership and collaboration agreement between the companies continuing uninterrupted.

The transaction consideration consists of an option fee, the issuance of a convertible note and fixed purchase price terms to acquire Trutino Biosciences once pre-defined milestones are achieved. The option fee and principal amount of the convertible note funded by Boehringer Ingelheim at the signing of the option will collectively fully finance Trutino Biosciences through the next major development milestones of Trutino Biosciences.

Boehringer Ingelheim and Trutino Biosciences were introduced in 2019 during one of Boehringer Ingelheim’s "Grass Roots Innovation" events in San Diego. From there, in 2020 the companies forged a multi-target strategic partnership on conditionally masked cytokines. Boehringer Ingelheim’s Grass Roots programs provide biotech entrepreneurs mentoring and access to expertise and possible funding. To learn more, visit Grass Roots Innovation.

On June 14, 2022 City of Hope, one of the largest cancer research and treatment organizations in the United States, reported that Philip Okala, chief operating officer at the University of Pennsylvania Health System, will join the organization as system president (Press release, City of Hope, JUN 14, 2022, View Source [SID1234615981]). In his role, Okala will be responsible for City of Hope’s portfolio of clinical care and research entities, which include City of Hope Los Angeles, City of Hope Orange County, Translational Genomics Research Institute (TGen), Beckman Research Institute of City of Hope and the recently acquired Cancer Treatment Centers of America. He will also have executive oversight of City of Hope’s medical foundation and clinical and research operations. Okala will report to Robert Stone, City of Hope’s chief executive officer, and join the organization in September of this year.

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Okala joins City of Hope after serving for the past five years as chief operating officer at the University of Pennsylvania Health System, which represents six acute care hospitals/health systems and the expansive Penn Medicine at Home enterprise, in addition to more than 43,000 employees, 8,900 credentialed physicians on staff across the system and approximately $9 billion in annual revenue. In his role, Okala had executive oversight of the health system’s hospitals, clinical service line operations, corporate emergency management and overall system integration. Prior to this role, Okala served for five years as senior vice president for business development at Penn Medicine, overseeing strategy and business development initiatives. He has previously held leadership roles at the Geisinger Health System, Roswell Park Cancer Institute, MD Anderson Cancer Center and the Michael E. DeBakey VA Medical Center.

"As we set the stage for City of Hope’s next 100 years of service to cancer patients and their families, I could not imagine a better leader to accelerate our mission than Phil Okala," said Robert Stone, the Helen and Morgan Chu Chief Executive Officer Distinguished Chair. "Phil has an extraordinary set of leadership skills and experience, managing operations and executive teams across a complex health system and research organization. His expertise will be immensely valuable as we further our goal to democratize cancer care and create a system that develops the next generation of research discoveries, treatment and care and makes them accessible to more patients, families and communities across the country."

Today’s leadership announcement is the latest milestone in City of Hope’s transformation into a national cancer research and treatment system. In recent years, City of Hope has grown substantially with the expansion of its clinical network in Southern California, addition of genomics leader TGen, launch of its employer cancer care benefits offering AccessHopeTM, the acquisition of Cancer Treatment Centers of America and a new cancer center in Orange County, California, scheduled to open in 2022.

"City of Hope’s vision to make cancer care more accessible to more people across the country is part of what really attracted me and got me excited about the opportunity," said Okala, incoming City of Hope system president. "When you talk to people who work at City of Hope or walk through the campus, you feel the culture, values and absolute commitment to the patient that comes through in each and everything they do. It’s a special place, and the system we’re building will allow even more people to experience the unique power and talent this organization has to offer patients in their moments of need."

City of Hope’s system of provider and research entities serves approximately 115,000 patients each year, with more than 11,000 team members, 575 physicians and more than 1,000 scientists and researchers across a network of locations in California, Arizona, Illinois and Georgia.

On June 14, 2022 Immunicom, Inc., a privately held clinical-stage biotechnology company with a transformative immuno-oncology platform, reported that it has been awarded $2 million by the National Cancer Institute (NCI) and National Institutes of Health (NIH) to initiate its first US-based clinical trial at the Baylor College of Medicine in Houston, Texas (Press release, Immunicom, JUN 14, 2022, View Source;Breast-Cancer [SID1234615980]). The trial [NIH/NCI Grant 1R44CA261565-01A1], to be conducted in collaboration with Dr. Mothaffar F. Rimawi, Professor of Medicine/Oncology and Executive Medical Director, Dan L. Duncan Cancer Comprehensive Center, Baylor College of Medicine, will evaluate the safety, tolerability, and efficacy of the FDA Breakthrough Immunopheresis LW-02 Molecular Ligand-Capture Column for treating refractory, hormone-resistant breast cancers.

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"We are honored to receive this grant from the NCI/NIH recognizing the potential of Immunopheresis therapy. This clinical trial is a monumental step for Immunicom to address unmet needs for patients with difficult-to-treat cancers," said Principal Investigator Dr. Robert Segal, Immunicom’s Chief Medical Officer. "We feel confident that further evaluation of Immunopheresis, both alone and as an adjunct to chemotherapy, will demonstrate that this is an essential new modality for immuno-oncology. Through this US-based trial, we will seek further evidence that Immunopheresis safely and effectively treats cancer and has a positive effect on the quality of patients’ lives, as has been observed in the Company’s three ongoing global trials conducted in 67 patients, with over 2,000 treatments completed to date."

The Company’s LW-02 Molecular Ligand-Capture technology, which received FDA Breakthrough designation in 2018, is designed to remove specific factors (sTNF-R1/2) shed by cancer cells that inhibit endogenous tumor necrosis factor alpha (TNF-α), a cytokine widely recognized for its tumoricidal behavior. In a process like dialysis, Immunopheresis therapy removes sTNF-R1/2 from plasma, helping kickstart endogenous TNF-α response to cancer without toxicities that increase the risk of side effects.

The exploratory study of 12 subjects will evaluate Immunopheresis therapy in metastatic, hormone-refractory ER+/HER2- breast cancer patients who have failed at least two lines of hormone therapy, and one to two lines of chemotherapy. These patients will be recruited to receive Immunopheresis LW-02 Column induction monotherapy over a two-week period, then in combination with low-dose chemotherapy for an additional 14 weeks. Throughout treatment, patients will be monitored for reduction of circulating sTNF-R1/2 and adverse events. Objective response and clinical benefit will be exploratory; quality-of-life/clinical function, circulating CT-DNA and tumor cells, and markers of an immunologic response (including in tissue) will also be evaluated. Clinical response to treatment and tumor burden will be monitored by standard RECIST v1.1/iRECIST criteria (MRI/CT), and follow-up for up to one year will include evaluating subjects for progression free survival (PFS), best overall response (BOR), overall response rate (ORR), and overall survival (OS).

Subtractive Therapy – Immunopheresis and the LW-02 Column

Immunicom employs a proprietary, high-affinity, molecular capture-ligand binding matrix within the LW-02 Column to remove specific cytokine receptors, soluble TNF-Receptors 1 and 2 (sTNFR-1/2), that are shed by cancer cells into the extracellular tumor microenvironment. sTNF-Rs serve as decoys, binding to tumor necrosis factor alpha (TNF-α) before it can bind to its membrane-embedded sTNF-R receptors to trigger several cell death pathways, as well as modulate antitumor cytotoxic T-cells and macrophage activity. The selective removal of decoy sTNF-Rs by the LW-02 Column allows the patient’s immune system to identify and aggressively attack the cancer.

Immunopheresis, like dialysis, is a subtractive therapy that occurs outside the body, in contrast to conventional drugs and biologics that are infused into the patient. Immunopheresis is thus intended to be much better tolerated than chemo- and immunotherapies, allowing for its use as an adjunct with these therapies, possibly in lower doses to reduce their toxicity. The Immunopheresis platform is a targeted removal therapy that can selectively remove any soluble factor. Immunicom has multiple cytokine and soluble targets under development, including IL-6, VEGF, IL-1 beta, and soluble PD-L1, with others to follow.

On June 14, 2022 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported a poster presentation on DecisionDx-Melanoma at the recent 2022 Fall Clinical Dermatology Conference for PAs & NPs (Press release, Castle Biosciences, JUN 14, 2022, View Source [SID1234615979]). The poster, titled "Attitudes of Patients with Cutaneous Melanoma Towards Prognostic Testing Using Gene Expression Profiling," shares results from a survey of 120 melanoma patients regarding prognostic testing with DecisionDx-Melanoma. The poster can be viewed here.

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"The number of invasive melanoma diagnoses has risen by 31% over the last decade,1 and in 2022 alone, it is estimated that melanoma will claim over 7,000 lives.2 For this reason, a diagnosis of malignant, invasive melanoma can be terrifying for patients," said Kyleigh LiPira, M.B.A., study author and chief executive officer of the Melanoma Research Foundation (MRF). "In the survey, a significant majority of patients desired testing with DecisionDx-Melanoma after receiving a melanoma diagnosis and appreciated the in-depth information provided by the results, regardless of whether they received low or high-risk scores."

Highlights from survey results:

90% of patients wanted prognostic information about their tumors at diagnosis.
Patients wanted DecisionDx-Melanoma testing to increase their knowledge about their disease (76.9%) and inform treatment decisions (46.2%).
More than 90% of patients felt the testing was useful and that they gained understanding (60.7%) and relief from uncertainty (39.3%).
Patients receiving results from their DecisionDx-Melanoma test did not experience decision regret, even among patients who received a DecisionDx-Melanoma Class 2 (high-risk) test result.
DecisionDx-Melanoma provides personalized information based on a patient’s biological risk of metastasis and recurrence that can aid clinicians and patients in making more informed and risk-aligned decisions about the management of their melanoma.

About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma (CM) metastasis or recurrence, as well as the risk of sentinel lymph node positivity, independent of traditional staging factors, and has been studied in more than 6,300 patient samples. Using tissue from the primary melanoma, the test measures the expression of 31 genes. Additionally, Castle has an ongoing collaboration with the National Cancer Institute (NCI) to link DecisionDx-Melanoma testing data with data from the Surveillance, Epidemiology and End Results (SEER) Program’s registries on CM cases. This collaboration has resulted in Castle’s analysis of 5,226 samples (clinically tested through December 31, 2018) in a study to evaluate melanoma-specific survival and overall survival; in this study, patients tested with DecisionDx-Melanoma had better survival rates than untested patients, and the data suggested that DecisionDx-Melanoma can accurately risk-stratify for disease progression to aid in risk-aligned treatment plans for improved patient outcomes and survival. The test has been validated in four archival risk of recurrence studies of 901 patients and six prospective risk of recurrence studies including more than 1,600 patients. Additionally, impact on patient management plans for one of every two patients tested has been shown in five multi-center/single-center studies including more than 800 patients. The consistent performance and accuracy demonstrated in these studies provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results. To predict risk of recurrence and likelihood of sentinel lymph node positivity, the Company utilizes its proprietary algorithms, i31-ROR and i31-SLNB, to produce an Integrated Test Result. Through March 31, 2022, DecisionDx-Melanoma has been ordered 97,288 times for patients with cutaneous melanoma.

On June 14, 2022 TILT Biotherapeutics (TILT), a clinical-stage biotechnology company developing cancer immunotherapies, reported it has completed the first close of its financing round raising $10.7 million (€10 million) (Press release, TILT Biotherapeutics, JUN 14, 2022, View Source [SID1234615978]). The round was led by Lifeline Ventures and was joined by Tesi (Finnish Industry Investment Ltd). The funding will be used to advance Phase I/II programs in Europe and the US, using TILT-123 plus immune checkpoint inhibitors against a range of cancers including ovarian, head & neck, and lung.

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The company also announces the appointment of Dr. Tuija Keinonen, PhD (Pharm), as Chair of the Board. Tuija brings specialist industry experience in life sciences business development and clinical trial operations across Europe and Asia.

TILT Biotherapeutics’ founder and CEO, Akseli Hemminki, a cancer clinician who has personally treated hundreds of cancer patients, said, "I’m delighted to announce a solid financing for the company, and to warmly welcome Tuija Keinonen as Chair of the Board. Tuija brings a wealth of experience which will be a great asset as we progress our pipeline of armed oncolytic viruses. These are showing excellent potential in the clinic to increase the anti-tumor benefits of checkpoint inhibitors for a range of cancers where there’s a pressing need for better therapies.

TILT Biotherapeutics’ Chair, Tuija Keinonen, said, "I’m able to use my international business and clinical operations expertise to support TILT’s growing clinical footprint. We now have several clinical trials running in Europe and the US and are planning more."

Lifeline Ventures’ Founding Partner, Timo Ahopelto, said, "We support resilient founders. We saw early on the enormous potential in TILT’s innovative approach to boost the patient’s T cell immune response to better enable it to find and destroy cancer cells."

"TILT is one of the most promising biotech companies in Finland. We are excited to back the development of the company’s innovative treatments for cancer types with currently limited treatment options. Despite the enormous developments in cancer treatments over the past decade, there is still a significant need for new therapies," said Miia Kaye, Investment Manager at Tesi.